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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)

NCTNCT02299089 (opens ClinicalTrials.gov in a new tab)Other idHS-12-455
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
12 participants (actual)
Sponsor
Camurus AB · Industry
Design
Randomized · Open label (no masking)
Countries
4 countries

France, Germany, Italy, Sweden

Start
Jan 2015
Primary completion
May 2016
Completion
Jun 2016
First posted
24 Nov 2014 (estimated)
Last update posted
15 Dec 2017
Conditions
Acromegaly · Neuroendocrine Tumors

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201520162017
  1. Ph 2

    Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)

    NCT02299089

    Jan 2015 to Jun 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy, and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a functional, well-differentiated NET, with carcinoid symptoms.

Interventions

  • octreotide FluidCrystal® injection depotDrug

Arms4

  • Experimental

    CAM2029 10 mg (NET)

    CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks

  • Experimental

    CAM2029 20 mg (NET)

    CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly

  • Experimental

    CAM2029 10 mg (Acromegaly)

    CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks

  • Experimental

    CAM2029 20 mg (Acromegaly)

    CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly

Primary outcomes6

Outcomes the sponsor listed as primary.

  1. Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC

    Time frame · Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)

    Registry description

    Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; AUC0-28d (day\*ng/mL). AUC0-28d: AUC from 0 to 28 days over the final dosing interval (day\*ng/mL) for Sandostatin LAR.

  2. Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC.

    Time frame · (Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)

    Registry description

    Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84 ; AUC0-28d (day\*ng/mL). AUC0-28d: AUC from 0 to 28 days over the dosing intervals (day\*ng/mL) for CAM2029 20 mg q4w and CAM2029 10 mg q2w (to estimate AUC0-28d for those patients receiving CAM2029 10 mg q2w, AUC0-14d was multiplied by a factor of 2 as an estimate of the AUC0-28d) dosing intervals

  3. Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough

    Time frame · Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)

    Registry description

    Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; Ctrough (ng/mL). Ctrough; Concentration levels assessed prior to next injection for the final (Sandostatin LAR) dosing interval (ng/mL).

  4. Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax

    Time frame · Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)

    Registry description

    Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; Cmax (ng/mL). Cmax (ng/mL): Maximum observed plasma concentration over the final (Sandostatin LAR) dosing interval (ng/mL)

  5. Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough

    Time frame · (Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)

    Registry description

    Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84; Ctrough (ng/mL). Ctrough; Concentration levels assessed prior to next injection for CAM2029 20 mg q4w and CAM2029 10 mg q2w dosing intervals (ng/mL)

  6. Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax.

    Time frame · (Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)

    Registry description

    Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84 ; Cmax (ng/mL). Cmax (ng/mL): Maximum observed plasma concentration over CAM2029 20 mg q4w and CAM2029 10 mg q2w dosing intervals (ng/mL)

Secondary outcomes(3)

  1. Number of Adverse Events and Serious Adverse Events

    Time frame · Day -28 to Day 84

    Registry description

    Safety (number of adverse events and serious adverse events) after repeated doses of CAM2029 (assessment period from Day 0 to Day 84) and single dose Sandostatin LAR (assessment period Day -28 to Day 0)

  2. CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly)

    Time frame · Day 84

    Registry description

    Data is presented as number of patients * Within the reference limits (see below) * Above ULN (Upper Limits of Normal) In the Acromegaly group both males and females were included the age was between 42-70 years. The IGF normal range for the different genders and age are presented below. REFERENCE VALUES Males (NMOL/L) 8.34-27.44 (41-45 years) 7.7-26.36 (46-50 years) 7.3-26.34 (51-55 years) 6.64-25.44 (56-60 years) 6.17-25.02 (61-65 years) 5.96-25.48 (66-70 years) Females (NMOL/L) 8.06-26.89 (41-45 years) 7.39-25.44 (46-50 years) 6.92-24.98 (51-55 years) 5.92-22.7 (56-60 years) 5.42-21.96 (61-65 years) 5.07-21.97 (66-70 years)

  3. CAM2029 Effect on Growth Hormone (GH) (Acromegaly)

    Time frame · Day 84

    Registry description

    GH (growth hormone) levels measured on Day 84 in patients with acromegaly

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)

Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC

GroupValue (day*ng/mL)Spread
Sandostatin LAR 10 mg (Acromegaly)6.23NA
Sandostatin LAR 30mg (Acromegaly)24.111.6
Sandostatin LAR 20 mg (NET)27.8NA
Sandostatin LAR 30 mg (NET)39.920.5
Primary outcomeMean· (Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)

Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC.

GroupValue (day*ng/mL)Spread
CAM2029 10 mg q2w (Acromegaly)92.936.8
CAM2029 20 mg q4w (Acromegaly)72.46.73
CAM2029 10 mg q2w (NET)72.9NA
CAM2029 20 mg q4w (NET)13537.8
Primary outcomeMean· Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)

Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough

GroupValue (ng/mL)Spread
Sandostatin LAR 10 mg (Acromegaly)0.225NA
Sandostatin LAR 30mg (Acromegaly)1.200.647
Sandostatin LAR 20 mg (NET)0.901NA
Sandostatin LAR 30 mg (NET)1.270.480
Primary outcomeMean· Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)

Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax

GroupValue (ng/mL)Spread
Sandostatin LAR 10 mg (Acromegaly)0.349NA
Sandostatin LAR 30mg (Acromegaly)1.410.693
Sandostatin LAR 20 mg (NET)1.68NA
Sandostatin LAR 30 mg (NET)2.481.79
Primary outcomeMean· (Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)

Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough

GroupValue (ng/ml)Spread
CAM2029 10 mg q2w (Acromegaly)1.320.422
CAM2029 20 mg q4w (Acromegaly)0.4030.342
CAM2029 10 mg q2w (NET)1.80NA
CAM2029 20 mg q4w (NET)1.810.817
Primary outcomeMean· (Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)

Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax.

GroupValue (ng/mL)Spread
CAM2029 10 mg q2w (Acromegaly)10.46.62
CAM2029 20 mg q4w (Acromegaly)13.44.31
CAM2029 10 mg q2w (NET)6.33NA
CAM2029 20 mg q4w (NET)16.38.67
Secondary and other outcome results(2)
Secondary outcomeCount of participants· Day -28 to Day 84

Number of Adverse Events and Serious Adverse Events

GroupValue (Participants)
CAM2029 10 mg q2w (Acromegaly)2
CAM2029 20 mg q4w (Acromegaly)4
CAM2029 10 mg q2w (NET)0
CAM2029 20 mg q4w (NET)2
Sandostatin LAR (Acromegaly)4
Sandostain LAR (NET)2
Secondary outcomeNumber· Day 84

CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly)

GroupValue (participants)
CAM2029 10 mg q2w (Acromegaly)2
CAM2029 20 mg q4w (Acromegaly)1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
CAM2029 10 mg q2w (Acromegaly)CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot Day 0-84–0 / 32 / 3
CAM2029 20 mg q4w (Acormegaly)CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot Day 0-84–0 / 44 / 4
CAM2029 10 mg q2w (NET)CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot Day 0-84–0 / 10 / 1
CAM2029 20 mg q4w (NET)CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot Day 0-84–1 / 42 / 4
Sandostatin LAR (Acromegaly)Sandostatin LAR Day-28 to day 0 All acromegaly patients, all treatment groups–0 / 74 / 7
Sandostatin LAR (NET)Sandostatin LAR Day -28 to day 0 All NET patients, all treatment groups–0 / 52 / 5

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2019

Octreotide SC depot in patients with acromegaly and functioning neuroendocrine tumors: a phase 2, multicenter study.

Pavel et al. 2019Cancer chemotherapy and pharmacologycited by 27

PMID 30535537DOI 10.1007/s00280-018-3734-1PUB-30535537

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: Acromegaly: * Male or female patients ≥18 years of age * Acromegaly currently treated with Sandostatin LAR NET: * Male or female patients ≥18 years of age * Functional, well-differentiated (Grade 1 or Grade 2) NET with symptoms of carcinoid syndrome (number of bowel movements and/or flushing) * Currently treated with Sandostatin LAR for symptom control Exclusion Criteria: Acromegaly: * Inadequate bone marrow function * Abnormal coagulation or chronic treatment with warfarin or coumarin derivates * Impaired liver, cardiac and/or renal function * Known gallbladder, bile duct disease or pancreatitis * Diabetes with poorly controlled blood glucose levels despite adequate therapy * Hypothyroidisms not adequately treated NET: * Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, pancreatic islet cell carcinoma, insulinoma, glucagonoma, gastrinoma, goblet cell carcinoid, typical and atypical lung carcinoids, large cell neuroendocrine carcinoma and small cell carcinoma * Carcinoid syndrome refractory to treatment with conventional doses of somatostatin analogues (SSAs) * Inadequate bone marrow function * Abnormal coagulation or chronic treatment with warfarin or coumarin derivates * Impaired liver, cardiac and/or renal function * Known gallbladder, bile duct disease or pancreatitis * Short-bowel syndrome * Diabetics with poorly controlled blood glucose levels despite adequate therapy * Hypothyroidism, not adequately treated

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